BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIAC CATHETER

    MDR report key: 5442053 · Received February 11, 2016

    Report

    Report Number
    MW5060230
    Event Type
    Injury
    Date Received
    February 11, 2016
    Date of Event
    February 11, 2016
    Report Date
    February 11, 2016
    Product Code
    DRF
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTED A F/U TO HIS PREVIOUS AE; "BTW, I AM ALL CLEAR MEDICALLY NOW SO IF MY HELP IS NEEDED FEEL FREE TO CALL ON ME." F/U TO PREVIOUSLY REPORTED AE FROM 01/21/2016: "MY FRIEND, MY CATHETERIZATION WENT WELL TODAY, I HAVE VERY MINIMAL ARTERY CLOSURE, NOT AN ISSUE AT ALL. GUESS ALL THE TUNA SALAD SANDWICHES I HAD FOR LUNCH OVER THE YEARS, AND SKIPPING HAMBURGERS PAID OFF! WHAT I DO HAVE THAT GIVES ME ONLY 44% HEART OUTPUT FLOW IS A MUSCLE ISSUE. THIS AS A RESULT OF HAVING A FAILURE OF ONE OF MY THREE ELECTRICAL CHANNELS THAT RUN DOWN THE SURFACE OF THE HEART. AT THAT TIME 10 YEARS AGO, THEY TOLD ME UP IN A (B)(6) HOSPITAL THAT IT WAS NOT A PROBLEM, AS YOU HAVE TWO MORE CHANNELS THERE AND YOU DON'T NEED ALL THREE. TURNS OUT NOW THAT THIS IMPACTS THE HEART MUSCLE OVER A LONG PERIOD OF TIME AND CAUSED MY MUSCLE PROBLEM NOW. RIGHT NOW I WILL BE TAKING MEDICINE FOR TREATMENT. IF MY PRESSURE GOES TO A LOW AND DANGEROUS NUMBER AT SOME POINT, THE CORRECTION WILL BE INSTALLING A PACEMAKER DEVICE. THE DOCTOR SAYS I WILL BE FINE BY SATURDAY TO FLY TO (B)(6) AND KEEP MY APPOINTMENTS AT (B)(6) THERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88873 CARDIAC CATHETER CARDIAC CATHETER DRF

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR